Surgical site marker delivery system

ABSTRACT

A site marker delivery system is provided that may be used in combination with a tissue cutting device for marking a biopsy site. The system includes a tube attached to a hub. A push-rod is slidably disposed within the lumen of the tube. The push-rod is advanced forward through the lumen of the tube causing a marker seated within the tube to be deployed at a biopsy site.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 60/618,868 filed Oct. 14, 2004 which is hereby incorporated byreference in its entirety.

FIELD OF THE INVENTION

The invention generally relates to a biopsy site marker delivery systemthat may be used with a biopsy tissue cutting device. More particularly,the invention relates to a biopsy site marker delivery system fornon-surgically implanting a site marker at a biopsy.

BACKGROUND OF THE INVENTION

In the field of breast cancer, stereotactically guided and percutaneousbiopsy procedures have increased in frequency as well as in accuracy asmodem imaging techniques allow the physician to locate lesions with everincreasing precision. However, for a given biopsy procedure, asubsequent examination of the biopsy site is very often desirable.

For example, in those cases where the lesion is found to be benign, afollow-up examination of the biopsy site may be conducted at a latertime. Where the lesion is found to be malignant, the physician may wantto place additional site markers to help guide the surgeon to themalignancy.

A number of procedures and devices for marking and locating particulartissue locations are known in the prior art. For example, location wireguides are well known for locating lesions, particularly in the breast.One such known device includes a tubular introducer needle and anattached wire guide, which has at its distal end, a helical coilconfiguration for locking into position about the targeted lesion. Theneedle is introduced into the breast and guided to the lesion site usingan imaging system of a known type, for example, X-Ray, ultrasound ormagnetic resonance imaging (MRI), at which time the helical coil at thedistant end is deployed about the lesion. Then, the needle may beremoved from the wire guide, which remains locked in position distallyabout the lesion for guiding a surgeon down the wire to the lesion siteduring subsequent surgery. While such a location system is effective, itis obviously intended and designed to be only temporary, and is removedonce the surgery or other procedure has been completed.

It is also known to employ biocompatible dyes or stains to mark breastlesions. First, a syringe containing the colorant is guided to thedetection lesion, using an imaging system. Later, during the extractionprocedure, the surgeon harvests a tissue sample from the stained tissue.However, while such staining techniques can be effective, it isdifficult to precisely localize the stain. Also, the stains aredifficult to detect fluoroscopically and may not always be permanent.

Additionally, it is known to implant markers directly into a patient'sbody using an invasive surgical technique. This enables a practitionerto later return to the site of the graft by identifying the rings, forevaluation purposes.

Each of the above systems and methods for marking a biopsy site hasdisadvantages associated with effectiveness, accuracy, and invasivesurgical techniques. Accordingly, what is needed is a site markerdelivery system for delivering a marker to a biopsy site, and deployingthe marker at the site effectively, accurately, and without the need foradditional invasive surgical procedures.

SUMMARY OF THE INVENTION

In one embodiment of the present invention, the marker delivery systemfurther includes a hub having a proximal end, a distal end and a channelextending between these ends. A tube having a lumen, a proximal end anda distal end, is attachable to the hub proximate the distal end thereof.The tube includes an aperture in communication with the lumen. Theaperture is formed through a portion of a side wall of the tubeproximate the distal end thereof.

A push-rod is dimensioned to be slidably passed through the channel ofthe hub and the lumen of the tube to the distal end thereof. Thepush-rod is operative to advance a marker seated in the lumen of thetube and out of the lumen through the aperture formed in the side wallof the tube.

A tube guide may be provided that is selectively attachable to anon-working end of a tissue cutting device to facilitate the properalignment of the tube with a channel of the tissue cutting device. Thetube guide includes proximal and distal ends and is formed with achannel extending between these ends.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an embodiment of a site marker deliverysystem according to the invention.

FIG. 1A is an enlarged view of a distal end of the site marker deliverysystem of FIG. 1 in area A after deployment of a site marker.

FIG. 1B is an enlarged view of a distal end of the site marker deliverysystem of FIG. 1 in area A before deployment of a site marker.

FIG. 2 is an exploded view of the embodiment of the site marker deliverysystem of FIG. 1.

FIG. 3A is an enlarged view of the hub and deployment trigger of theembodiment of the site marker delivery system of FIG. 1 in a firstposition.

FIG. 3B is an enlarged view of the hub and deployment trigger of theembodiment of the site marker delivery system of FIG. 1 in a secondposition.

FIG. 4A is a perspective view of a tissue cutting device that may beused with the embodiment of the site marker delivery system of FIG. 1.

FIG. 4B is a cross-section of the tissue cutting device of FIG. 4Aillustrating the channel formed along the longitudinal access of thetissue cutting device.

FIG. 5 is a fragmentary view of the tissue cutting device of FIG. 4A andthe tube guide of the embodiment of FIG. 1.

FIG. 5A is an enlarged view of the tube guide of the site markerdelivery system of FIG. 1.

FIG. 6 is a side view of the site marker delivery system of FIG. 1A in afirst position prior to deployment of the site marker.

FIG. 7 is a side view of the site marker delivery system of FIG. 1attached to the tissue cutting device in a second position after thesite marker has been deployed.

FIG. 8 is a flow diagram of a method of using the site marker deliverysystem of FIG. 1 to mark a biopsy site.

FIG. 9 is an alternative embodiment of a site marker delivery system.

DETAILED DESCRIPTION OF THE INVENTION

An embodiment of a site marker delivery system 10 that may be used incombination with a tissue cutting device for efficiently, accurately andsanitarily depositing a marker at a biopsy site, is disclosed. Themarker delivery system 10 includes advantages over conventional deliverydevices which are sometimes difficult to use, often result in inaccurateplacement of the marker within the biopsy cavity, and allow forrelatively large volumes of biological fluids to spill out from thebiopsy device onto other equipment, medical professionals, thesurrounding work area and floor.

The site marker delivery system 10 is formed of medical grade materials,for example, stainless steel, plastic and rubber. The site markerdelivery system 10 includes universal features that allows the system tobe used with a number of tissue cutting devices of different sizes,particularly with regard to an inner diameter of an inner cannula andthe length of the cutting element of a particular tissue cutting device.The system 10 is adaptable for use in conventional biopsy procedureswhich may be performed manually and stereo-tactically. Other advantagesprovided by the site marker delivery system 10 over conventional markerdelivery devices will become apparent from reading the following.

a. Hub

FIG. 1 illustrates an embodiment of a site marker delivery system 10according to the invention. The marker delivery system 10 includes a hub12 having a proximal end 14 and a distal end 16. The hub 12 is formedwith a channel 15 (as best seen in FIGS. 3A-3B) that extends between theproximal 14 and distal 16 ends.

In one embodiment, the hub 12 includes a tactile indicator 40 adjacentthe proximal end 14 that is indicative of the circumferentialorientation of an aperture 24 of a tube 18 to be described hereinafter.The tactile indicator 40 may include a marking 64 that allows theindicator 40 to be visible in low light conditions as an additionalmeans of indicating the orientation of the aperture 24 of the tube 18.

b. Tube

A tube 18 having a lumen (not shown) is provided having a proximal end20 and distal end 22. The tube 18 is fixedly attachable to the hub 12adjacent the distal end 16 of the hub 12. As mentioned above, the tube18 includes an aperture 24 that is in communication with the lumen. Theaperture 24 is formed through a portion of a side-wall of the tube 18proximate the distal end 22. In one embodiment, the tube 18 isdimensioned to slidably pass through a channel C of a tissue cuttingdevice (See FIG. 4B).

The tube 18 is preferably formed of a substantially rigid medical gradematerial such as stainless steel, plastic or other materials suitable. Amarker (M) may be seated within the tube 18. It is preferred that themarker M is seated adjacent a proximal end of the aperture 24 (See FIG.6). To retain marker M within tube 18 at least one retention tab 41 maybe provided. Prior to deployment, retention tab 41 is depressed inwardlyfrom an outer surface of tube 18 so as to form a lip to prevent a markerM from prematurely deploying out of aperture 24 (See FIG. 1B). Onceejection of the marker M is facilitated (to be explained in furtherdetail below), the marker M is pushed against retention tab 41,overcoming the spring force in retention tab 41 such that retention tab41 is forced upwardly (See FIG. 1A) to allow passage of marker M throughto aperture 24.

In one embodiment, the tube may further include an inclined wall 42formed proximate a distal end 43 of the aperture 24 (See FIG. 1A). Theinclined wall 42 operates as a ramp that assists in facilitating theejection of the marker M out of the aperture 24 (to be explained infurther detail below).

c. Tube Guide

A tube guide 26 may be provided. The tube guide 26 is selectivelyattachable to a non-working end of a tissue cutting device. The tubeguide 26 includes a proximal end 28 and a distal end 30. The tube guide26 is formed with a channel 32 that extends between the proximal 28 anddistal 30 ends (See FIG. 5).

Preferably, the tube guide 26 includes at least one attachment pin 36disposed on an exterior wall thereof. The attachment pin 36 isconstructed for engaging a complimentary mounting groove 38 formed onthe non-working end of the tissue cutting device so as to key the tubeguide to the tissue cutting device. After the tube guide 26 is keyed tothe tissue cutting device, the channel 32 of the tube guide 26 islongitudinally aligned with the channel C of the tissue cutting device.Accordingly, tube guide 26 operates to maintain the orientation betweenthe marker delivery system 10 and the tissue cutting device.

As best illustrated in FIG. 6, the proximal end 28 of the tube guide 26is formed as a funnel shaped wall 45. The funnel shaped wall 45 operatesto direct the tube 18 into the channel 32 of the tube guide 26 such thatthe tube 18 can be advanced through the channel C of the tissue cuttingdevice. In this fashion, the tube 26 can be directed into the channel 32of the tube guide without having to visibly guide the tube 18 into thechannel 32, unlike conventional marker delivery devices that requiredthat the apparatus holding the markers be visibly guided into a channelC of a tissue cutting device.

As shown in FIG. SA, the tube guide 26 preferably includes a first fluidsealing ring 46 disposed on its exterior wall adjacent the distal end 30and a second fluid sealing ring 48 disposed within the channel 32adjacent the distal end 30. The first and second fluid sealing rings 46,48 operate to prevent bodily fluids from spilling out through the tissuecutting device or the site marker delivery system when the biopsy siteis being marked. This helps maintain a safe, clean, and sanitaryenvironment for medical personnel and patients.

The tube guide 26 may also include an air venting aperture 50 that hasan inner diameter less than an inner diameter of the channel 32 of thetube guide 26. The disparate diameters insures that the tube 18 cannotbe erroneously fitted into the air venting aperture 50 causing it to beout of alignment with the channel C of the tissue cutting device.

d. Push-Rod

A push-rod 34 is dimensioned to slidably pass through the channel 15 ofthe hub 12 and the lumen of the tube 18 to the distal end 22 of the tube18. The push-rod 34 is operable to advance the marker M seated in thelumen of the tube 18 out of the lumen through the aperture 24. In oneembodiment, the push-rod 34 has an outer diameter that is substantiallycontiguous with the lumen of the tube 18. In this fashion, the push-rod34 operates to close or block the aperture 24 such that after the markerM has been deployed it can not fall back into the aperture 24.

e. Deployment Trigger

The site marker delivery system 10 preferably also includes a deploymenttrigger 44 that is selectively attachable to the proximal end 14 of thehub 12. As seen in FIG. 2, the push rod 34 is attachable to a firstsurface 54 of the deployment trigger 44 such that the deployment trigger44 is operable to advance the push rod 24 toward the distal end 22 ofthe tube 18 when the deployment trigger 44 is being attached to theproximal end 14 of the hub 12.

Preferably, the deployment trigger 44 is formed as a push plate havingopposing surfaces and at least one retaining arm 52 extending from thefirst surface 54. The at least one retaining arm 52 operates to engage acomplimentary retaining rim 56 (best seen in FIG. 3A) disposed adjacentthe proximal end 14 of the hub 12. The engagement of the at least oneretaining arm 52 and the retaining rim 56 operates to lock the push rod34 in place after the marker has been advanced out through the aperture24 of the tube 18. The engagement procedure provides a tactile andaudible indication to the user of the site marker delivery system 10that the marker has been deployed. The tactile indication is forcefeedback from snapping the at least one retaining arm 52 onto theretaining rim 56. The audible indication is provided by the useractually hearing a “snapping” sound when the deployment trigger 44 isengaged with the hub 12.

As best illustrated in FIG. 3A, the deployment trigger 44 also includesa spring 58 disposed between the proximal end 14 of the hub 12 and thedeployment trigger 44. The spring 58 concentrically surrounds a proximalend of the push rod 34 wherein a first end 60 of the spring 58frictionally engages a central portion of the deployment trigger 44 anda second end 62 of the spring 58 frictionally engages the proximal end14 of the hub 12. The spring 58 is adapted to maintain the longitudinalalignment between the deployment trigger 44 and the proximal end 14 ofthe hub 12. This allows for the push-rod 34 to be substantiallystabilized when being axially advanced toward the distal end 22 the tube18.

f. Method of Using the Marker Delivery System

FIG. 8 illustrates a method of using the site marker delivery system 10in combination with a tissue cutting device for the purpose of marking abiopsy site. The method begins at 100 with attaching the tube guide 26to the non-working end of the tissue cutting device. This step ensuresthat the channel 32 of the tube guide 26 is in alignment with thechannel C of the tissue cutting device.

At 110, the method continues by sliding the tube 18 through the channel32 of the tube guide 26 and the channel C of the tissue cutting devicetoward the distal end of the tissue cutting device.

At 120, the user of the site marker delivery system 10 receives atactile indication from contacting the distal end of the tissue cuttingdevice with the distal end 22 of the tube 18. This indicates that themarker delivery system 10 is in position for deployment of the sitemarker.

At 130, the method continues by aligning the aperture 24 of the tube 18with an aperture formed proximate the distal end of the tissue cuttingdevice. The tactile indicator 40 assists the user in orientating theaperture 24 with the aperture in the tissue cutting device. The methodadvances to 140.

At 140, the biopsy site is marked by depositing a marker seated in thelumen of the tube 18 at the biopsy site. This is accomplished byadvancing the push-rod 34 through the channel 15 of the hub 12 and thelumen of the tube 18 toward the distal end 22 of the tube 18 until themarker M is discharged from the lumen and out through the aperture 24.If a retention tab 41 is provided, this step may also pushing retentiontab 41 upwardly such that marker M may be advanced to the aperture 24 bypush-rod 34.

At 150, the push-rod is locked in place after the marker M has beendischarged from the lumen through the aperture 24 by engaging thedeployment trigger 44 onto the proximal end 14 of the hub 12. In thisfashion, the push rod 34 operates to prevent the marker from fallingback into the aperture 24 during removal of the side marker deliverysystem 10 and the tissue cutting device from the biopsy site.

Referring now to FIG. 9, an alternative embodiment of an end deploymentsite marker delivery system 200 is shown. End deployment site markerdelivery system 200 includes a cannula 202, a push rod 204, and a handle206. Cannula 202 is hollow and defines an inner lumen having a proximalend 208 and a distal end 210. Both proximal and distal ends 208 and 210are open. In one embodiment, proximal end 208 further includes at leastone retaining rim 212 (to be explained in further detail below).

In one embodiment, positioned slightly in board of distal end 210 is atleast one holding tab 214. Holding tab 214 is formed on an internalsurface of cannula 202 and is sized so as to frictionally engage aportion of a site marker 216 (to be explained in further detail below).In one embodiment holding tab 214 is constructed of a suitable materialhaving a predetermined degree of flexibility such that a predeterminedamount of force may flex the holding tab out of engagement with sitemarker 216.

Push rod 204 is connected to a deployment plunger 218 at its proximalend. Push rod 204 further includes a distal end 220 that is selectivelycontactable with site marker 216. Push rod 204 is dimensioned to slidabypass through the lumen of cannula 202 to the distal end 210 of cannula202. However, push rod 204 further may be dimensioned so as to besubstantially contiguous with the lumen of cannula 202 to block or closeopen distal end 210 such that after marker 216 has been deployed, itcannot reenter cannula 202.

Deployment plunger 218 is formed as a push plate having opposingsurfaces 222, 224 and at least one retaining arm 226 extending from oneof the opposing surfaces 222. Retaining arm 226 operates to engageretaining rim 212 of cannula 202 in a complementary fashion. Engagementof retaining arm 226 and retaining rim 212 operates to lock push rod 204in place after marker 216 has been advanced out though distal end 210.The engagement of retaining arm 226 and 212 provides a tactile (forcefeedback from snapping retaining arm 226 onto retaining rim 212) andaudible (the “snapping” sound generated when retaining arm 226 engagesretaining rim 212) indication to the user of site marker delivery system200 that marker 216 has been deployed.

Handle 206 is connected to cannula 202. In one embodiment, handle 206 isintegrally formed with cannula 202. Handle 206 provides a convenientgripping portion for grasping cannula 202 to maintain the position ofcannula 202 while activating the deployment plunger 218.

Marker 216 is positioned within open distal end 210 of cannula. In oneembodiment, marker 216 includes a head portion 228 and a body portion230, where head portion 228 is sized to be at least slightly larger thanthe outside diameter of cannula 202 such that head portion 228 remainsoutside of the lumen of cannula 202. While head portion 228 isconfigured as a “cap” in FIG. 9, it is understood that other geometriesmay be employed for head portion 228 such as a blunt end or a trocartip. Further, it is also understood that marker 216 need not be providedwith a head portion 228 at all.

Body portion 230 is sized to at least partially slidably pass intodistal end 210 of cannula 202. However, body portion 230 is also sizedsuch that it frictionally engages holding tab 214. Holding tab 214retains marker 216 to cannula 202 until it is deployed via push rod 204.

When deployment plunger 218 is activated, push rod 204 moves throughcannula 202 until distal end 220 of push rod 204 comes into contact withan end 232 of body portion 230. Push rod 204 then over comes thefrictional force of holding tab 214 and pushes marker 216 out throughdistal end 210 of cannula 202 into the body cavity. When deploymentplunger 218 has reached distal end 210 of cannula 202, retaining arm 226engages retaining rim 212 thereby indicating deployment of marker 216.

The foregoing embodiments of the site marker delivery system isdisclosed for illustrative purposes. Many adaptations and modificationswill become apparent to one of ordinary skill in the art upon readingthe above descriptions. The scope of the invention should be determinedwith reference to the appended claims, along with the full scope ofequivalence to which such claims are entitled.

1-31. (canceled)
 32. A marker delivery system, comprising: a cannula having proximate and distal ends, wherein both of said proximal and distal ends are open, said cannula defining a lumen extending between said proximal and distal ends; wherein said cannula further includes at least one holding tab connected to an internal surface of said lumen of said cannula, adjacent to said distal end of said cannula, said holding tab serving to frictionally engage at least a portion of a marker to said cannula; and a push rod dimensioned to slidably pass through said lumen of said cannula, entering in said distal end, said push rod being operable to advance said marker past said holding tab of said lumen out of said lumen and into a body cavity.
 33. The marker delivery system of claim 32, further including a deployment plunger connected to a push rod.
 34. The marker delivery system of claim 33, wherein said deployment plunger includes a push plate having opposing surfaces and at least one retaining arm extending away from said one of said opposing faces, said retaining arm being operable to engage a complementary retaining rim disposed on said proximal end of said cannula to lock said push rod in place.
 35. The marker delivery system of claim 33, wherein said deployment plunger is integrally connected to said push rod.
 36. The marker delivery system of claim 32, wherein said cannula includes a pair of holding tabs arranged in an opposing manner, said pair of holding tabs cooperating to frictionally retain at least a portion of a marker to said cannula.
 37. The marker delivery system of claim 32, wherein said holding tab is constructed of a flexible material.
 38. The marker delivery system of claim 32, wherein the marker is at least partially retained within said cannula.
 39. The marker delivery system of claim 32 further including a handle connected to a portion of said cannula.
 40. The marker delivery system of claim 39, wherein said handle is integrally connected to said cannula. 